EX-99.1 2 c05058exv99w1.htm EXHIBIT 99.1 Exhibit 99.1
Exhibit 99.1
(SANUWAVE LOGO)
     
SANUWAVE Health, Inc.
  Lippert/Heilshorn & Associates
Barry Jenkins, CFO
  Anne Marie Fields
Bernie Laurel, VP of Sales and Marketing
  212-838-3777
678-578-0103
  afields@lhai.com
FOR IMMEDIATE RELEASE
SANUWAVE HEALTH REPORTS SECOND QUARTER FINANCIAL RESULTS AND
PROVIDES BUSINESS UPDATE
Launched orthoPACEfor Musculoskeletal Treatments in Europe
Nearing Completion of Patient Follow-Up in the U.S. Phase III Pivotal Trial of
dermaPACE
to Treat Diabetic Foot Ulcers
ALPHARETTA, Ga. (August 13, 2010) — SANUWAVE Health, Inc. (OTC BB: SNWV), an emerging medical technology company focused on regenerative medicine, today reported financial results for the three and six months ended June 30, 2010 and provided a business update.
Christopher M. Cashman, President and CEO of SANUWAVE, said, “We made considerable progress during the first six months of 2010. We completed enrollment and are now approaching the end of the patient follow-up phase in our U.S. Phase III pivotal trial of dermaPACE™ to treat diabetic foot ulcers (DFU). We also launched the orthoPACE™ device in Europe for use in orthopedic, trauma and sports medicine indications following receipt of CE mark approval. Both accomplishments are core to our strategic development plan and advance our goal to commercialize our regenerative medicine devices in wound care and orthopedics.”
Commenting further on the dermaPACE™ trial, Mr. Cashman added, “The completion of patient enrollment in our Phase III pivotal trial has brought us closer to our goal to commercialize dermaPACE™ in the U.S. for the treatment of diabetic foot ulcers, which represent a $2 billion market opportunity in the U.S. and remain a major area of unmet medical need. We expect to complete the patient follow-up phase of this trial in early September, to report top-line results in the fourth quarter, to file our Premarket Approval Application (PMA) with the FDA no later than the first quarter of 2011, and, pending a favorable response from the FDA, to launch dermaPACE™ in the U.S. in 2011. We continue to speak with leading U.S. surgeons and wound care specialists about a clinical study of dermaPACE™ to treat venous and complex chronic wounds, which represent the largest portion of the $5 billion U.S. advanced wound care market.”

 

 


 

Commenting further on the orthoPACE™ product launch, Mr. Cashman said, “We were pleased about the successful on-time launch of our orthoPACE™ device for musculoskeletal treatments in certain European markets at the end of the quarter. We shipped our first devices to distributors in July 2010. The orthoPACE™ has a compact, portable design that allows for treatments to be performed by a single operator in the hospital or office setting. The device has a proven success rate in orthopedic and sports medicine conditions such as nonunion fracture and tendinopathy that is equal to and often superior to that of surgery — usually with just one procedure and without the risks, complications and lengthy recovery inherent with invasive surgery. Most procedures can be performed in less than 15 minutes, and patients can return home the same day. Patients can bear weight immediately and are able to return to normal activity within a few days. Because PACE™ treatment is completely non-invasive there is no risk of infection or scarring. Importantly, it preserves the opportunity for any future treatment options as it does not change the biomechanics of the underlying musculoskeletal system. This combination of efficiency and proven outcomes across a broad range of treatment applications will allow us to position orthoPACE™ as the premium extracorporeal shock wave technology for musculoskeletal conditions in Europe.”
Also in the second quarter of 2010, the Company was granted a European patent that provides the Company exclusive rights in human and animal treatment devices that include the novel use of piezoelectric fibers to produce acoustic energy in the shock wave spectrum. This provides a significant competitive advantage for the Company’s PACE™ technology as the smaller, targeted focal volume created by piezoelectric fiber technology allows for the delivery of shock waves with greater accuracy by focusing the energy to a precise point in the targeted tissue while minimizing exposure of the delivered energy to the surrounding tissue.
Second Quarter Financial Results
SANUWAVE’s financial results for the second quarter of 2010 reflect the Company’s ongoing research and development of PACE™ technology for the dermaPACE™ DFU study and development work for orthopedic and cosmetic uses.
Revenues for the three months ended June 30, 2010 were $117,000, compared with $142,000 in the corresponding 2009 quarter. The decrease is primarily the result of declining revenue from SANUWAVE’s legacy Evotron™ device as the Company eliminated its European sales and marketing staff in 2009 in order to focus resources in the U.S. The first shipments of the new orthoPACE™ devices were made in July 2010 and the corresponding revenue and cost of goods sold will be recorded in the third quarter of 2010.
For the second quarter of 2010, the Company reported a loss from continuing operations of $2.7 million, compared with a loss from continuing operations of $1.7 million for the same period in 2009. The higher loss is due primarily to increased research and development expenses related to ongoing clinical work and to higher general and administrative expenses. General and administrative expenses were higher due to increases in non-cash stock compensation expense to $454,000 for the second quarter of 2010, from $134,000 in the prior-year quarter, due to new grants of options and restricted stock to management and directors of the Company in September 2009 and January 2010. In addition, higher general and administrative expenses were the result of bonus expense of $147,000 recorded during the 2010 second quarter compared with a bonus credit of $303,000 recorded during same period in 2009, which was the result of a reversal of the 2008 bonus accrual determined not to be payable due to the Company’s capital constraints at the time.

 

 


 

The net loss for the second quarter of 2010 was $2.7 million or ($0.22) per share, compared with net income of $1.1 million or $0.10 per diluted share reported during the second quarter of 2009. The second quarter of 2009 included a gain, net of tax, of $2.5 million on the sale of the Company’s veterinary division in June 2009.
First Half Financial Results
Revenues for the six months ended June 30, 2010 were $260,000, compared with $404,000 in the corresponding 2009 period. The decrease is primarily the result of declining revenue from SANUWAVE’s legacy Evotron™ device as the Company eliminated its European sales and marketing staff in 2009 in order to focus resources in the U.S. The first shipments of the new orthoPACE™ devices were made in July 2010 and the corresponding revenue and cost of goods sold will be recorded in the third quarter of 2010.
For the six months ended June 30, 2010, the Company reported a loss from continuing operations of $5.7 million, compared with a loss from continuing operations of $3.8 million for the same period in 2009. The higher loss is due primarily to increased research and development expenses related to ongoing clinical work and to higher general and administrative expenses. General and administrative expenses were higher due to increases in non-cash stock compensation expense to $938,000 for the six months ended June 30, 2010, from $267,000 in the prior-year period, due to new grants of options and restricted stock to management and directors of the Company in September 2009 and January 2010. In addition, higher general and administrative expenses were the result of bonus expense of $297,000 recorded during first half of 2010 compared with a bonus credit of $150,000 recorded during same period in 2009, which was the result of a reversal of the 2008 bonus accrual determined not to be payable due to the Company’s capital constraints at the time.
The net loss for the six months ended June 30, 2010 was $5.7 million or ($0.46) per share, compared with net loss of $750,000 or ($0.07) per share reported during the same period of 2009. The six months ended June 30, 2009 included a gain, net of tax, of $2.5 million on the sale of the Company’s veterinary division in June 2009.
As of June 30, 2010 the Company had cash and cash equivalents of $277,000, compared with $1.8 million as of December 31, 2009. The Company’s net cash used by continuing operations for the six months ended June 30, 2010 was $3.0 million, compared with $4.0 million for the same period of 2009. The reduction in the use of cash from continuing operations in 2010 was primarily due to the timing of accounts payable payments. Subsequent to quarter end, the Company issued a convertible promissory note for $500,000 on July 13, 2010.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of non-invasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE’s portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration. SANUWAVE intends to apply its Pulsed Acoustic Cellular Expression (PACE™) technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE™, is CE marked for treatment of the skin and subcutaneous soft tissue and has completed enrollment in its FDA-approved Phase III, pivotal Investigational Device Exemption (IDE) trial in the U.S. for the treatment of diabetic foot

 

 


 

ulcers (DFU). SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that this technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA-approved Ossatron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron®, Evotron™ and recently introduced orthoPACE™ devices in Europe.
Safe Harbor Statement
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
(FINANCIAL TABLES FOLLOW)

 

 


 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
                 
    June 30,     December 31,  
    2010     2009  
    (Unaudited)     (Audited)  
ASSETS
CURRENT ASSETS
               
Cash and cash equivalents
  $ 277,258     $ 1,786,369  
Accounts receivable — trade, net
    69,683       47,966  
Inventory
    547,544       592,589  
Prepaid expenses
    132,842       121,157  
Due from Pulse Veterinary Technologies, LLC
    151,102       127,878  
 
           
TOTAL CURRENT ASSETS
    1,178,429       2,675,959  
 
               
PROPERTY AND EQUIPMENT, at cost, less accumulated depreciation
    37,342       88,706  
 
               
OTHER ASSETS
    31,820       32,169  
 
               
INTANGIBLE ASSETS, at cost, less accumulated amortization
    1,993,916       2,147,295  
 
               
ASSETS HELD FOR SALE
    591,435       922,956  
 
           
TOTAL ASSETS
  $ 3,832,942     $ 5,867,085  
 
           
LIABILITIES
CURRENT LIABILITIES
               
Accounts payable
  $ 1,816,924     $ 1,069,423  
Payroll and related
    809,171       509,905  
Accrued expenses
    376,360       629,029  
Promissory notes
    1,518,428        
Liabilities related to discontinued operations
    655,061       655,061  
 
           
TOTAL CURRENT LIABILITIES
    5,175,944       2,863,418  
 
               
NOTES PAYABLE, RELATED PARTIES
    9,329,678       8,887,981  
 
           
TOTAL LIABILITIES
    14,505,622       11,751,399  
 
           
 
               
COMMITMENTS AND CONTINGENCIES
           
 
               
GOING CONCERN
           
 
               
STOCKHOLDERS’ DEFICIT
COMMON STOCK, par value $0.001, 50,000,000 shares authorized, 12,509,657 issued and outstanding
    12,510       12,510  
 
               
ADDITIONAL PAID-IN CAPITAL
    33,679,293       32,741,593  
 
               
ACCUMULATED OTHER COMPREHENSIVE LOSS
    17,703       21,864  
 
               
RETAINED DEFICIT
    (44,382,186 )     (38,660,281 )
 
           
TOTAL STOCKHOLDERS’ DEFICIT
    (10,672,680 )     (5,884,314 )
 
           
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
  $ 3,832,942     $ 5,867,085  
 
           
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
                                 
    Three Months Ended     Three Months Ended     Six Months Ended     Six Months Ended  
    June 30,     June 30,     June 30,     June 30,  
    2010     2009     2010     2009  
 
                               
REVENUES
  $ 117,226     $ 141,965     $ 260,328     $ 404,047  
 
                               
COST OF REVENUES
    40,936       38,381       88,580       98,663  
 
                       
 
                               
GROSS PROFIT
    76,290       103,584       171,748       305,384  
 
                       
 
                               
OPERATING EXPENSES
                               
Research and development
    895,651       808,774       1,981,625       1,622,285  
General and administrative
    1,498,236       653,590       3,096,760       1,903,167  
Depreciation
    185,202       43,378       379,934       103,846  
Amortization
    76,690       76,689       153,379       153,378  
 
                       
TOTAL OPERATING EXPENSES
    2,655,779       1,582,431       5,611,698       3,782,676  
 
                       
 
                               
OPERATING LOSS
    (2,579,489 )     (1,478,847 )     (5,439,950 )     (3,477,292 )
 
                       
 
                               
OTHER INCOME (EXPENSE)
                               
Gain/(loss) on sale of assets
    2,065       (13,651 )     2,065       (13,651 )
Transitional services provided to Pulse Veterinary Technologies, LLC
    90,125       33,750       180,125       33,750  
Interest expense, net
    (240,243 )     (191,017 )     (457,524 )     (329,075 )
 
                               
Gain (loss) on foreign currency exchange
    392       (28,325 )     (6,621 )     (37,773 )
 
                       
 
                               
TOTAL OTHER INCOME (EXPENSE)
    (147,661 )     (199,243 )     (281,955 )     (346,749 )
 
                       
 
                               
LOSS FROM CONTINUING OPERATIONS BEFORE INCOME TAXES
    (2,727,150 )     (1,678,090 )     (5,721,905 )     (3,824,041 )
 
                               
INCOME TAX EXPENSE
                       
 
                       
 
                               
LOSS FROM CONTINUING OPERATIONS
    (2,727,150 )     (1,678,090 )     (5,721,905 )     (3,824,041 )
 
                       
 
                               
DISCONTINUED OPERATIONS
                               
Income from discontinued operations, net of tax
          258,821             581,306  
Gain on sale of veterinary division, net of tax
          2,492,273             2,492,273  
 
                       
INCOME FROM DISCONTINUED OPERATIONS
          2,751,094             3,073,579  
 
                               
NET INCOME (LOSS)
    (2,727,150 )     1,073,004       (5,721,905 )     (750,462 )
 
                               
OTHER COMPREHENSIVE INCOME (LOSS), net of tax
                               
Foreign currency translation adjustments
    (3,593 )     1,906       (4,161 )     (47,226 )
 
                       
TOTAL COMPREHENSIVE INCOME (LOSS)
  $ (2,730,743 )   $ 1,074,910     $ (5,726,066 )   $ (797,688 )
 
                       
 
                               
EARNINGS (LOSS) PER SHARE:
                               
Loss from continuing operations — basic
  $ (0.22 )   $ (0.15 )   $ (0.46 )   $ (0.35 )
 
                       
Loss from continuing operations — diluted
  $ (0.22 )   $ (0.15 )   $ (0.46 )   $ (0.35 )
 
                       
Income from discontinued operations — basic
  $     $ 0.25     $     $ 0.28  
 
                       
Income from discontinued operations — diluted
  $     $ 0.25     $     $ 0.28  
 
                       
Net earnings (loss) — basic
  $ (0.22 )   $ 0.10     $ (0.46 )   $ (0.07 )
 
                       
Net earnings (loss) — diluted
  $ (0.22 )   $ 0.10     $ (0.46 )   $ (0.07 )
 
                       
 
                               
Weighted average shares outstanding — basic
    12,509,657       11,009,657       12,509,657       11,009,657  
 
                       
Weighted average shares outstanding — diluted
    12,509,657       11,009,657       12,509,657       11,009,657  
 
                       
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
                 
    Six Months Ended     Six Months Ended  
    June 30,     June 30,  
    2010     2009  
 
               
CASH FLOWS FROM OPERATING ACTIVITIES
               
Net loss from continuing operations
  $ (5,721,905 )   $ (3,824,041 )
Adjustments to reconcile net loss to net cash used by operating activities
               
Amortization
    153,379       153,378  
Accrued interest
    460,125       330,642  
Depreciation
    379,934       103,846  
Change in allowance for doubtful accounts
    9,007       (33,400 )
(Gain) loss on sale of property and equipment
    (2,065 )     13,651  
Stock-based compensation
    937,700       267,392  
Changes in assets — (increase)/decrease
               
Accounts receivable — trade
    (30,724 )     (3,509 )
Inventory
    45,045       104,943  
Prepaid expenses
    (11,685 )     (18,959 )
Due from Pulse Veterinary Technologies, LLC
    (23,224 )     (157,009 )
Other assets
    349       (430 )
Assets held for sale
    2,516        
Changes in liabilities — increase/(decrease)
               
Accounts payable
    747,501       (698,787 )
Payroll and related
    299,266       (160,100 )
Accrued expenses
    (252,669 )     (98,255 )
 
           
NET CASH USED BY CONTINUING OPERATIONS
    (3,007,450 )     (4,020,638 )
NET CASH PROVIDED BY DISCONTINUED OPERATIONS
          1,018,505  
 
           
NET CASH USED BY OPERATING ACTIVITIES
    (3,007,450 )     (3,002,133 )
 
           
 
               
CASH FLOWS FROM INVESTING ACTIVITIES
               
Continuing operations
               
Proceeds from sale of property and equipment
    2,500        
Purchase of property and equipment
          (21,147 )
 
           
NET CASH PROVIDED (USED) BY CONTINUING OPERATIONS
    2,500       (21,147 )
NET CASH PROVIDED BY DISCONTINUED OPERATIONS
          3,540,948  
 
           
NET CASH PROVIDED BY INVESTING ACTIVITIES
    2,500       3,519,801  
 
           
 
               
CASH FLOWS FROM FINANCING ACTIVITIES
               
Continuing operations
               
Proceeds from promissory notes
    1,500,000        
Proceeds from notes payable, related parties
          2,125,000  
 
           
NET CASH PROVIDED BY FINANCING ACTIVITIES
    1,500,000       2,125,000  
 
           
 
               
FOREIGN CURRENCY TRANSLATION ADJUSTMENTS
    (4,161 )     (47,226 )
 
           
 
               
NET INCREASE (DECREASE) IN CASH
    (1,509,111 )     2,595,442  
 
               
CASH, BEGINNING OF PERIOD
    1,786,369       543,626  
 
           
CASH, END OF PERIOD
  $ 277,258     $ 3,139,068  
 
           
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